a Retrospective Study on the Systemic Treatment of LPP and FFA

NCT ID: NCT06512766

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2023-02-01

Brief Summary

This retrospective study aims to assess the effectiveness of systemic treatments for lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) in patients treated at the Erasmus MC University Medical Center. LPP and FFA are chronic inflammatory hair disorders leading to irreversible hair loss. The study evaluates treatment responses to systemic medications, including hydroxychloroquine, methotrexate, cyclosporine A, and retinoids.

Detailed Description

Cicatricial alopecia, also known as scarring alopecia, refers to a group of rare chronic inflammatory hair disorders resulting in irreversible hair loss. Lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) are the most common forms of primary lymphocytic cicatricial alopecia, affecting predominantly postmenopausal women. These conditions lead to significant quality of life impairment due to their chronic nature and the lack of effective, standardized treatment protocols. The study aimed to address the gap in evidence-based treatment guidelines by investigating the effectiveness of various systemic therapies currently used in clinical practice. The retrospective cohort study reviewed medical records of patients diagnosed with LPP or FFA at the Department of Dermatology, Erasmus MC University Medical Center, from July 2016 to July 2022.

Conditions

Cicatricial Alopecia; Lichen Planopilaris; Lichen Plano-Pilaris; Frontal Fibrosing Alopecia; Hair Diseases; Scarring Alopecia; Hair Loss/Baldness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Lichen planopilaris

Patients in this group were diagnosed and treated for lichen planopilaris (LPP), a form of primary lymphocytic cicatricial alopecia. Treatment options included hydroxychloroquine (HCQ), methotrexate (MTX), cyclosporine A (CsA), and retinoids. The effectiveness of these treatments varied among patients. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments were not consistent.

Hydroxychloroquine

Intervention Type: DRUG

Patients in this group were treated with hydroxychloroquine (HCQ), a systemic medication commonly used as a first-line treatment due to its ease of use and established safety profile. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Methotrexate

Intervention Type: DRUG

This group consists of patients treated with methotrexate (MTX), a systemic medication often used as a second-line treatment for its effectiveness in reducing inflammation and controlling autoimmune responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Cyclosporine A

Intervention Type: DRUG

Patients in this group were treated with cyclosporine A (CsA), a potent immunosuppressive agent used for its effectiveness in controlling severe inflammatory responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Retinoids

Intervention Type: DRUG

This cohort includes patients treated with retinoids, which are used for their ability to modulate cell growth and differentiation. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Frontal fibrosing alopecia

Patients in this group were diagnosed and treated for frontal fibrosing alopecia (FFA), a form of primary lymphocytic cicatricial alopecia. Treatment options included hydroxychloroquine (HCQ), methotrexate (MTX), cyclosporine A (CsA), and retinoids. The effectiveness of these treatments varied among patients. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments were not consistent.

Hydroxychloroquine

Intervention Type: DRUG

Patients in this group were treated with hydroxychloroquine (HCQ), a systemic medication commonly used as a first-line treatment due to its ease of use and established safety profile. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Methotrexate

Intervention Type: DRUG

This group consists of patients treated with methotrexate (MTX), a systemic medication often used as a second-line treatment for its effectiveness in reducing inflammation and controlling autoimmune responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Cyclosporine A

Intervention Type: DRUG

Patients in this group were treated with cyclosporine A (CsA), a potent immunosuppressive agent used for its effectiveness in controlling severe inflammatory responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Retinoids

Intervention Type: DRUG

This cohort includes patients treated with retinoids, which are used for their ability to modulate cell growth and differentiation. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Interventions

Hydroxychloroquine

Patients in this group were treated with hydroxychloroquine (HCQ), a systemic medication commonly used as a first-line treatment due to its ease of use and established safety profile. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Intervention Type: DRUG

Methotrexate

This group consists of patients treated with methotrexate (MTX), a systemic medication often used as a second-line treatment for its effectiveness in reducing inflammation and controlling autoimmune responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Intervention Type: DRUG

Cyclosporine A

Patients in this group were treated with cyclosporine A (CsA), a potent immunosuppressive agent used for its effectiveness in controlling severe inflammatory responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Intervention Type: DRUG

Retinoids

This cohort includes patients treated with retinoids, which are used for their ability to modulate cell growth and differentiation. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of LPP or FFA
• 18 years or older

Exclusion Criteria

• Other forms of cicatricial alopecia than LPP or FFA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

DirkJan Hijnen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DirkJan Hijnen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

9434

Identifier Type: -

Identifier Source: org_study_id